Surgical instruments

ABSTRACT

A surgical instrument includes an elongated transmission waveguide defining a longitudinal axis. The transmission waveguide has a distal end and a proximal end. The at least one strike surface is formed on the proximal end and is configured to receive vibratory energy.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional application claiming the benefitunder 35 U.S.C. §121 to U.S. patent application Ser. No. 11/726,760,entitled SURGICAL INSTRUMENTS, filed on Mar. 22, 2007, now U.S. Pat. No.8,226,675, the entire disclosure of which is hereby incorporated byreference herein.

BACKGROUND

The present application is related to the following, U.S. patentapplications, filed on Mar. 22, 2007 which are incorporated herein byreference in their respective entireties:

(1) U.S. patent application Ser. No. 11/726,625, published as U.S.Patent Application Publication No. 2008/0234710 on Sep. 25, 2008,entitled ULTRASONIC SURGICAL INSTRUMENTS;

(2) U.S. patent application Ser. No. 11/726,620, now U.S. Pat. No.8,142,461, issued Mar. 27, 2012, entitled SURGICAL INSTRUMENTS; and

(3) U.S. patent application Ser. No. 11/726,621, published as U.S.Patent Application Publication No. 2008/0234709 on Sep. 25, 2008,entitled ULTRASONIC SURGICAL INSTRUMENTS AND CARTILAGE BONE SHAPINGBLADES THEREFOR.

Ultrasonic instruments, including both hollow core and solid coreinstruments, are used for the safe and effective treatment of manymedical conditions. Ultrasonic instruments, and particularly solid coreultrasonic instruments, are advantageous because they may be used to cutand/or coagulate organic tissue using energy in the form of mechanicalvibrations transmitted to a surgical end effector at ultrasonicfrequencies. Ultrasonic vibrations, when transmitted to organic tissueat suitable energy levels and using a suitable end effector, may be usedto cut, dissect, elevate, coagulate or cauterize tissue, or to separatemuscle tissue off bone. Ultrasonic instruments utilizing solid coretechnology are particularly advantageous because of the amount ofultrasonic energy that may be transmitted from an ultrasonic transducer,through a waveguide, to the surgical end effector. Such instruments maybe used for open procedures or minimally invasive procedures, such asendoscopic or laparoscopic procedures, wherein the end effector ispassed through a trocar to reach the surgical site.

Activating or exciting the end effector (e.g., cutting blade) of suchinstruments at ultrasonic frequencies induces longitudinal vibratorymovement that generates localized heat within adjacent tissue,facilitating both cutting and coagulation. Because of the nature ofultrasonic instruments, a particular ultrasonically actuated endeffector may be designed to perform numerous functions, including, forexample, cutting and coagulating.

Ultrasonic vibration is induced in the surgical end effector byelectrically exciting a transducer, for example. The transducer may beconstructed of one or more piezoelectric or magnetostrictive elements inthe instrument hand piece. Vibrations generated by the transducersection are transmitted to the surgical end effector via an ultrasonicwaveguide extending from the transducer section to the surgical endeffector. The waveguides and end effectors are designed to resonate atthe same frequency as the transducer. Therefore, when an end effector isattached to a transducer the overall system frequency is the samefrequency as the transducer itself.

The amplitude of the longitudinal ultrasonic vibration at the tip, d, ofthe end effector behaves as a simple sinusoid at the resonant frequencyas given by:d=A sin(ωt)where:

-   ω=the radian frequency which equals 2π times the cyclic frequency,    f; and-   A=the zero-to-peak amplitude.-   The longitudinal excursion is defined as the peak-to-peak (p-t-p)    amplitude, which is just twice the amplitude of the sine wave or 2A.

Solid core ultrasonic instruments may be divided into two types, singleelement end effector devices and multiple-element end effector. Singleelement end effector devices include instruments such as scalpels andball coagulators. Multiple-element end effectors may be employed whensubstantial pressure may be necessary to effectively couple ultrasonicenergy to the tissue. Multiple-element end effectors such as clampingcoagulators include a mechanism to press tissue against an ultrasonicblade. Ultrasonic clamp coagulators may be employed for cutting andcoagulating tissue, particularly loose and unsupported tissue.Multiple-element end effectors that include an ultrasonic blade inconjunction with a clamp apply a compressive or biasing force to thetissue to promote faster coagulation and cutting of the tissue, withless attenuation of blade motion.

Orthopedic surgery or orthopedics is the branch of surgery concernedwith acute, chronic, traumatic, and overuse injuries and other disordersof the musculoskeletal system. Orthopedic surgeons address mostmusculoskeletal ailments including arthritis, trauma and congenitaldeformities using both surgical and non-surgical means. Orthopedicprocedures include hand surgery, shoulder and elbow surgery, total jointreconstruction (arthroplasty), pediatric orthopedics, foot and anklesurgery, spine surgery, musculoskeletal oncology, surgical sportsmedicine, and orthopedic trauma. These procedure often require the useof specialized surgical instruments to treat relatively softermusculoskeletal tissue (e.g., muscle, tendon, ligament) and relativelyharder musculoskeletal tissue (e.g., bone). Quite often, theseorthopedic surgical instruments are hand operated and a single proceduremay require the exchange of a number of instruments. It may bedesirable, therefore, for a variety of electrically powered andunpowered ultrasonic instruments to perform these orthopedic surgicalprocedures with more efficiency and precision than is currentlyachievable with conventional orthopedic surgical instruments whileminimizing the need to exchange instruments when cutting, shaping,drilling different types of musculoskeletal tissue.

SUMMARY

In one general aspect, the various embodiments are directed to asurgical instrument that includes an elongated transmission waveguidedefining a longitudinal axis. The transmission waveguide has a distalend and a proximal end. The at least one strike surface is formed on theproximal end and is configured to receive vibratory energy.

FIGURES

The novel features of the various embodiments are set forth withparticularity in the appended claims. The various embodiments, however,both as to organization and methods of operation, together with furtherobjects and advantages thereof, may best be understood by reference tothe following description, taken in conjunction with the accompanyingdrawings as follows.

FIG. 1 illustrates one embodiment of an ultrasonic system.

FIG. 2 illustrates one embodiment of a connection union/joint for anultrasonic instrument.

FIG. 3 illustrates one embodiment of an ultrasonic subassembly that maybe configured to couple to the ultrasonic hand piece assembly of theultrasonic system described in FIG. 1.

FIG. 4 is a top perspective view of one embodiment of an ultrasonicinstrument.

FIG. 5 is a cross-sectional view of one embodiment of the ultrasonicinstrument shown in FIG. 4 taken along the longitudinal axis “L”.

FIG. 6 is a cross-sectional view of one embodiment of an vibrationalsurgical instrument taken along the longitudinal axis “L”.

FIG. 7 is a cross-sectional view of one embodiment of a vibrationalsurgical instrument taken along the longitudinal axis “L”.

FIG. 8 is a cross-sectional view of one embodiment of an ultrasonicinstrument taken along the longitudinal axis “L”.

FIG. 9 is a cross-sectional view of one embodiment of an ultrasonicinstrument taken along the longitudinal axis “L”.

FIG. 10 illustrates a side view of one embodiment of an ultrasonicinstrument comprising an impact zone.

FIG. 11 illustrates a side view of one embodiment of an ultrasonicinstrument comprising an impact zone.

FIG. 12 illustrates a side view of one embodiment of an ultrasonicinstrument comprising an impact zone.

FIG. 13 illustrates a side view of one embodiment of an ultrasonicinstrument comprising an impact zone.

FIGS. 14-17 illustrate one embodiment of an ultrasonic instrumentcomprising an end effector at a distal end; FIG. 14 is a sideperspective view of one embodiment of the ultrasonic instrument with theclamp jaw in a closed position; FIGS. 15 and 16 are side perspectiveviews of the ultrasonic instrument with the clamp jaw in partially openpositions; and FIG. 17 is side perspective view of the ultrasonicinstrument with the clamp arm assembly in a closed position.

FIGS. 18-20 illustrate one embodiment of an end effector that may beemployed with the ultrasonic instrument discussed in FIGS. 14-17; FIG.18 is a top perspective view of one embodiment of the end effector withthe clamp arm assembly in a closed position; FIG. 19 is a topperspective view of one embodiment of the end effector with the clamparm assembly in an open position; and FIG. 20 is an exploded view of oneembodiment of the end effector with the clamp jaw in an open position.

FIGS. 21-24 illustrate a clamp jaw transitioning from an open positionin FIG. 21 to a closed position in FIG. 24 and intermediate positions inFIGS. 22 and 23.

FIGS. 25 and 26 illustrate one embodiment of an end effector that may beemployed with the ultrasonic instrument discussed in FIGS. 14-17; FIG.25 is a top perspective view of one embodiment of the end effector withthe clamp arm assembly in an open position; and FIG. 26 is an explodedview of one embodiment of the end effector with the clamp jaw in an openposition.

DESCRIPTION

Before explaining embodiments of the present invention in detail, itshould be noted that the invention is not limited in its application oruse to the details of construction and arrangement of parts illustratedin the accompanying drawings and description. The illustrativeembodiments of the invention may be implemented or incorporated in otherembodiments, variations and modifications, and may be practiced orcarried out in various ways. For example, the surgical instruments andblade configurations disclosed below are illustrative only and not meantto limit the scope or application of the invention. Furthermore, unlessotherwise indicated, the terms and expressions employed herein have beenchosen for the purpose of describing the illustrative embodiments of thepresent invention for the convenience of the reader and are not for thepurpose of limiting the invention.

The various embodiments described herein are generally directed tosurgical instruments. Although these surgical instruments may beemployed in orthopedic surgical procedures, the described embodimentsare not limited in this context as these instruments may find usefulapplications outside of this particular branch of medicine. The variousembodiments described herein are directed to surgical instruments thatmay be used in a stand alone or in combination with ultrasonicallydriven surgical instruments. In some embodiments, the surgicalinstruments may be driven either manually or electrically, or may bedriven manually and electrically in combination. Surgical instrumentsconfigured to operate in multiple powered and unpowered states modes mayreduce the total number of instruments in the operating room, reducesthe number of instrument exchanges for a given procedure, and reducesthe number of instruments that have to be sterilized for a givenprocedure. In other embodiments, surgical instruments may attain usefullongitudinal vibrational resonance to assist cutting, reshaping, orcoagulating tissue without an electrically driven actuator or anultrasonic transducer. In yet other embodiments, electrically poweredultrasonic instruments may be used in combination with manual techniquesto carry out surgical procedures with greater efficiency and precision.

Examples of ultrasonic instruments are disclosed in U.S. Pat. Nos.5,322,055 and 5,954,736 and in combination with ultrasonic blades andsurgical instruments disclosed in U.S. Pat. Nos. 6,309,400 B2,6,278,218B1, 6,283,981 B1, and 6,325,811 B1, for example, areincorporated herein by reference in their entirety. These referencesdisclose ultrasonic instrument design and blade designs where alongitudinal node of the blade is excited. Because of asymmetry orasymmetries, these blades exhibit transverse and/or torsional motionwhere the characteristic “wavelength” of this non-longitudinal motion isless than that of the general longitudinal motion of the blade and itsextender portion. Therefore, the wave shape of the non-longitudinalmotion will present nodal positions of transverse/torsional motion alongthe tissue effector while the net motion of the active blade along itstissue effector is non-zero (i.e., will have at least longitudinalmotion along the length extending from its distal end, an antinode oflongitudinal motion, to the first nodal position of longitudinal motionthat is proximal to the tissue effector portion). Certain embodimentswill now be described in the form of examples to provide an overallunderstanding of the principles of the structure, function, manufacture,and use of the devices and methods disclosed herein. One or more ofthese embodiments are illustrated in the accompanying drawings in theform of illustrative examples. Those of ordinary skill in the art willunderstand that the devices and methods specifically described hereinand illustrated in the accompanying drawings are non-limiting exampleembodiments and that the scope of the various embodiments is definedsolely by the claims. The features illustrated or described inconnection with one example embodiment may be combined with the featuresof other embodiments. Such modifications and variations are intended tobe included within the scope of the claims.

FIG. 1 illustrates one embodiment of an ultrasonic system 10. In theillustrated embodiment, the ultrasonic system 10 comprises an ultrasonicsignal generator 12 coupled to an ultrasonic transducer 14, a hand pieceassembly 60 comprising a hand piece housing 16, and an end effector 50.The end effector 50 may have a chisel like shape adapted and configuredto cut bone tissue, may have a rounded end adapted and configured todrill small holes in bone tissue, and/or may configured to cut,coagulate, and/or shape tissue. The ultrasonic transducer 14, which isknown as a “Langevin stack”, generally includes a transduction portion18, a first resonator or end-bell 20, and a second resonator orfore-bell 22, and ancillary components. The ultrasonic transducer 14 ispreferably an integral number of one-half system wavelengths (nλ/2) inlength as will be described in more detail later. An acoustic assembly24 includes the ultrasonic transducer 14, a mount 26, a velocitytransformer 28, and a surface 30.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping the hand piece assembly60. Thus, the end effector 50 is distal with respect to the moreproximal hand piece assembly 60. It will be further appreciated that,for convenience and clarity, spatial terms such as “top” and “bottom”also are used herein with respect to the clinician gripping the handpiece assembly 60. However, surgical instruments are used in manyorientations and positions, and these terms are not intended to belimiting and absolute.

The distal end of the end-bell 20 is connected to the proximal end ofthe transduction portion 18, and the proximal end of the fore-bell 22 isconnected to the distal end of the transduction portion 18. Thefore-bell 22 and the end-bell 20 have a length determined by a number ofvariables, including the thickness of the transduction portion 18, thedensity and modulus of elasticity of the material used to manufacturethe end-bell 20 and the fore-bell 22, and the resonant frequency of theultrasonic transducer 14. The fore-bell 22 may be tapered inwardly fromits proximal end to its distal end to amplify the ultrasonic vibrationamplitude as the velocity transformer 28, or alternately may have noamplification. A suitable vibrational frequency range may be about 20 Hzto 120 kHz and a well-suited vibrational frequency range may be about30-70 kHz and one example operational vibrational frequency may beapproximately 55.5 kHz.

Piezoelectric elements 32 may be fabricated from any suitable material,such as, for example, lead zirconate-titanate, lead meta-niobate, leadtitanate, or other piezoelectric crystal material. Each of positiveelectrodes 34, negative electrodes 36, and the piezoelectric elements 32has a bore extending through the center. The positive and negativeelectrodes 34 and 36 are electrically coupled to wires 38 and 40,respectively. The wires 38 and 40 are encased within a power cable 42and electrically connectable to the ultrasonic signal generator 12 ofthe ultrasonic system 10.

The ultrasonic transducer 14 of the acoustic assembly 24 converts theelectrical signal from the ultrasonic signal generator 12 intomechanical energy that results in primarily longitudinal vibratorymotion of the ultrasonic transducer 14 and the end effector 50 atultrasonic frequencies. A suitable generator is available as modelnumber GEN04, from Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. Whenthe acoustic assembly 24 is energized, a vibratory motion standing waveis generated through the acoustic assembly 24. The amplitude of thevibratory motion at any point along the acoustic assembly 24 may dependupon the location along the acoustic assembly 24 at which the vibratorymotion is measured. A minimum or zero crossing in the vibratory motionstanding wave is generally referred to as a node (i.e., where motion isusually minimal), and an absolute value maximum or peak in the standingwave is generally referred to as an anti-node (i.e., where motion isusually maximal). The distance between an anti-node and its nearest nodeis one-quarter wavelength (λ/4).

The wires 38 and 40 transmit an electrical signal from the ultrasonicsignal generator 12 to the positive electrodes 34 and the negativeelectrodes 36. The piezoelectric elements 32 are energized by theelectrical signal supplied from the ultrasonic signal generator 12 inresponse to a foot switch 44 to produce an acoustic standing wave in theacoustic assembly 24. The electrical signal causes disturbances in thepiezoelectric elements 32 in the form of repeated small displacementsresulting in large compression forces within the material. The repeatedsmall displacements cause the piezoelectric elements 32 to expand andcontract in a continuous manner along the axis of the voltage gradient,producing longitudinal waves of ultrasonic energy. The ultrasonic energyis transmitted through the acoustic assembly 24 to the end effector 50via an ultrasonic transmission waveguide 46.

In order for the acoustic assembly 24 to deliver energy to the endeffector 50, all components of the acoustic assembly 24 must beacoustically coupled to the end effector 50. The distal end of theultrasonic transducer 14 may be acoustically coupled at the surface 30to the proximal end of the ultrasonic transmission waveguide 46 by athreaded connection such as a stud 48.

The components of the acoustic assembly 24 are preferably acousticallytuned such that the length of any assembly is an integral number ofone-half wavelengths (nλ/2), where the wavelength λ is the wavelength ofa pre-selected or operating longitudinal vibration drive frequency f_(d)of the acoustic assembly 24, and where n is any positive integer. It isalso contemplated that the acoustic assembly 24 may incorporate anysuitable arrangement of acoustic elements.

The ultrasonic end effector 50 may have a length substantially equal toan integral multiple of one-half system wavelengths (λ/2). A distal end52 of the ultrasonic end effector 50 may be disposed near an antinode inorder to provide the maximum longitudinal excursion of the distal end52. When the transducer assembly is energized, the distal end 52 of theultrasonic end effector 50 may be configured to move in the range of,for example, approximately 10 to 500 microns peak-to-peak, andpreferably in the range of about 30 to 150 microns at a predeterminedvibrational frequency.

The ultrasonic end effector 50 may be coupled to the ultrasonictransmission waveguide 46. The ultrasonic end effector 50 and theultrasonic transmission guide 46 as illustrated are formed as a singleunit construction from a material suitable for transmission ofultrasonic energy such as, for example, Ti6Al4V (an alloy of Titaniumincluding Aluminum and Vanadium), Aluminum, Stainless Steel, or otherknown materials. Alternately, the ultrasonic end effector 50 may beseparable (and of differing composition) from the ultrasonictransmission waveguide 46, and coupled by, for example, a stud, weld,glue, quick connect, or other suitable known methods. The ultrasonictransmission waveguide 46 may have a length substantially equal to anintegral number of one-half system wavelengths (nλ/2), for example. Theultrasonic transmission waveguide 46 may be preferably fabricated from asolid core shaft constructed out of material that propagates ultrasonicenergy efficiently, such as titanium alloy (i.e., Ti-6Al-4V) or analuminum alloy, for example.

The ultrasonic transmission waveguide 46 comprises a longitudinallyprojecting attachment post 54 at a proximal end to couple to the surface30 of the ultrasonic transmission waveguide 46 by a threaded connectionsuch as the stud 48. In the illustrated embodiment, the ultrasonictransmission waveguide 46 comprises a plurality of stabilizing siliconerings or compliant supports or silicon rings are 56 positioned at aplurality of nodes. The silicone rings 56 dampen undesirable vibrationand isolate the ultrasonic energy from a removable sheath 58 assuringthe flow of ultrasonic energy in a longitudinal direction to the distalend 52 of the end effector 50 with maximum efficiency.

As shown in FIG. 1, the removable sheath 58 is coupled to the distal endof the handpiece assembly 60. The sheath 58 generally includes anadapter or nose cone 62 and an elongated tubular member 64. The tubularmember 64 (e.g., outer tube) is attached to the adapter 62 and has anopening extending longitudinally therethrough. The sheath 58 may bethreaded or snapped onto the distal end of the housing 16. Theultrasonic transmission waveguide 46 extends through the opening of thetubular member 64 and the silicone rings 56 isolate the ultrasonictransmission waveguide 46 therein.

The adapter 62 of the sheath 58 may be fabricated from plastic such asUltem®, aluminum, or any suitable material, and the tubular member 64may be fabricated from stainless steel. Alternatively, the ultrasonictransmission waveguide 46 may have polymeric material surrounding it toisolate it from outside contact.

The distal end of the ultrasonic transmission waveguide 46 may becoupled to the proximal end of the end effector 50 by an internalthreaded connection, preferably at or near an antinode. It iscontemplated that the end effector 50 may be attached to the ultrasonictransmission waveguide 46 by any suitable means, such as a welded jointor the like. Although the end effector 50 may be detachable from theultrasonic transmission waveguide 46, it is also contemplated that theend effector 50 and the ultrasonic transmission waveguide 46 may beformed as a single unitary piece.

In one embodiment, the handpiece housing 16 of the ultrasonic handpieceassembly 60 may be configured to receive or accommodate a mechanicalimpact such as, for example, a mallet blow or hand blow, and impartenergy into the end effector 50 when the hand piece assembly 60 is in apowered or an unpowered state. In another embodiment, the handpieceassembly 60 may comprise a strike plate assembly such as those describedbelow in FIGS. 10-13, for example. Thus, in use a clinician may employthe handpiece assembly 60 in a powered state using the ultrasonicvibrations generated by the transduction portion 18 to cut and coagulaterelatively soft musculoskeletal tissue using a chisel shaped endeffector 50. With the handpiece assembly 60 in a powered or an unpoweredstate, the clinician may deliver a strike to the distal end of thehousing 16 manually or with employing an osteotome mallet to chiselrelatively hard musculoskeletal tissue such as bone.

FIG. 2 illustrates one embodiment of a connection union/joint 70 for anultrasonic instrument. In the illustrated embodiment, the connectionunion/joint 70 may be formed between the attachment post 54 of theultrasonic transmission waveguide 46 and the surface 30 of the velocitytransformer 28 at the distal end of the acoustic assembly 24. Theproximal end of the attachment post 54 comprises a female threadedsubstantially cylindrical recess 66 to receive a portion of the threadedstud 48 therein. The distal end of the velocity transformer 28 also maycomprise a female threaded substantially cylindrical recess 68 toreceive a portion of the threaded stud 40. The recesses 66, 68 aresubstantially circumferentially and longitudinally aligned.

FIG. 3 illustrates one embodiment of an ultrasonic subassembly 118 thatmay be configured to couple to the ultrasonic hand piece assembly 60 ofthe ultrasonic system 10 described in FIG. 1. In the illustratedembodiment, the ultrasonic subassembly 118 may be configured to coupleto the surface 30 of the ultrasonic system 10 described in FIG. 1. Inone embodiment, the ultrasonic subassembly 118 comprises a sheath orouter tube 150, an ultrasonic transmission waveguide 152, and the endeffector 50 having a distal end 52 at an anti-node. The outer tube 150has an opening extending longitudinally therethrough. The ultrasonictransmission waveguide 152 comprises a distal end 122 and a proximal end124 and defines a longitudinal axis “L”. The proximal end 124 comprisesa neck or transition portion 126 to attach or couple to the ultrasonictransmission surface 30 of the hand-piece assembly 60 by a stud, weld,glue, quick connect, or other known attachment methods, for example. Itwill be appreciated the shape of the neck 126 may be configured toprovide efficient ultrasonic coupling to the surface 30. In theillustrated embodiment, the neck 126 comprises a female threadedsubstantially cylindrical recess 128 to receive a portion of thethreaded stud 48 therein. The silicone rings 56 dampen undesirablevibration and isolate the ultrasonic energy from the removable outertube 150. A flange or proximal stop 140 is integrally formed and tunedwith the ultrasonic transmission waveguide 152 and is explained infurther detail below.

Although the ultrasonic subassembly 118 may be ultrasonically coupled tothe hand piece assembly 60 as described herein, those of ordinary skillin the art will understand that the various embodiments of theultrasonic instruments disclosed herein as well as any equivalentstructures thereof could conceivably be effectively used in connectionwith other known ultrasonic instruments without departing from the scopethereof. Thus, the embodiments disclosed herein should not be limited touse only in connection with the example ultrasonic instrument describedabove.

FIG. 4 is a top perspective view of one embodiment of an ultrasonicinstrument 120. FIG. 5 is a cross-sectional view of one embodiment ofthe ultrasonic instrument 120 taken along the longitudinal axis “L”.With reference to FIGS. 4 and 5, in the illustrated embodiment, thesurgical instrument 120 comprises the ultrasonic subassembly 118 shownin FIG. 3. The ultrasonic instrument 120 comprises the ultrasonictransmission waveguide 152, the outer tube 150, and the end effector 50.The ultrasonic instrument 120 is well-suited for effectingmusculoskeletal tissue comprising bones, muscles, joints, and theassociated periarticular tissues such as tendons, ligaments, cartilage,joints, and spinal discs. Tissue effects comprise cutting, coagulating,and drilling. The end effector 50 may have a chisel like shape adaptedand configured to cut bone tissue or may have a rounded end adapted andconfigured to drill small holes in bone tissue. The ultrasonicinstrument 120 is adapted to couple to the hand piece assembly 60 of theultrasonic system 10 in the manner described with respect to ultrasonicsubassembly 118 described in FIG. 3. In one embodiment, the ultrasonicinstrument 120 may be coupled to the hand piece assembly 60 with by athreaded connection such as the stud 48 or may be coupled by weld, glue,quick connect, or other suitable known methods.

The ultrasonic instrument 120 comprises a distal end 122 and a proximalend 124 and defines a longitudinal axis “L”. The proximal end 124comprises the neck or transition portion 126 that protrudes from theproximal end 124. The neck portion 126 may be attached to the ultrasonictransmission surface 30 by a stud, weld, glue, quick connect, or otherknown attachment methods, for example. The proximal end 124 comprisesthe female threaded substantially cylindrical recess 128 to receive aportion of the threaded stud 48 therein. The ultrasonic instrument 120is ultrasonically coupled to the hand piece assembly 60.

The ultrasonic instrument 120 comprises a “slap hammer” portion 130, agripping portion 132, and a longitudinally extending end effectorportion 134. The slap hammer portion 130 comprises a slap hammer 136that is slideably movable in the direction indicated by arrow 142 over aproximal shaft 138 to the flange or proximal stop 140. The grippingportion 132 comprises a grip 148 positioned distally beyond the proximalstop 140 positioned over a proximal sleeve 156 (e.g., bushing). A distalportion of the ultrasonic transmission waveguide 152 is positionedinside the longitudinal opening extending through the outer tube 150portion of the end effector portion 134. The grip 148 is fixedly mountedby a ring or circumferential projection 154. The circumferentialprojection 154 may be formed integrally with the distal portion of theultrasonic transmission waveguide 152 or may fixedly mounted thereto.

The distal portion of the ultrasonic transmission waveguide 152comprises a plurality of the stabilizing silicone rings or compliantsupports 56 positioned at a plurality of nodes. The silicone rings 56dampen undesirable vibration and isolate the ultrasonic energy from theouter tube 150 assuring the flow of ultrasonic energy in a longitudinaldirection to the distal end 52 of the end effector 50 with maximumefficiency.

The transition portion 126, the proximal shaft 138, the proximal stop140, and the distal portion of the ultrasonic transmission waveguide 152may be formed as a single unitary piece or may be removably attached toeach other. The transition portion 126, the proximal shaft 138, theproximal stop 140, and the distal portion of the ultrasonic transmissionwaveguide 152 form an ultrasonic transmission waveguide that may betuned and coupled to the surface 30 of the hand piece assembly 60 toamplify the amplitude of the mechanical vibrations generated by theultrasonic transducer 14 as discussed with reference to FIG. 1. Theultrasonic instrument 120 may be tuned such that the mechanicaldisplacements caused by the ultrasonic vibrations are efficientlytransferred from the ultrasonic transducer 14 to the end effector 50such that the effector experiences axial longitudinal displacements.

The slap hammer 136 is slideably movable over the proximal shaft 138 inthe direction indicated by arrow 142. The slap hammer 136 comprises agripping surface 158 and a sliding weight 160 that travels axially inline with the end effector 50. When the slap hammer 136 is moved axiallytowards the distal end 122, a circumferential distal surface 144 of theslap hammer 136 impacts a proximal surface 146 of the proximal stop 140.The proximal surface 146 defines an area to receive vibratory energy inthe form of mechanical impacts. The resulting impacts are transmittedthrough the ultrasonic transmission waveguide 152 to drive the endeffector 50 at the distal end 122 into the musculoskeletal tissue toeffect treatment. The sliding weight 160 assists in imparting energyupon impact. The circumferential proximal surface 146 forms an impactzone.

In use, a clinician may employ the ultrasonic hand piece assembly 60coupled to the ultrasonic instrument 120 to effect musculoskeletaltissue. In one phase the end effector 50 may be operated ultrasonically(e.g., powered state). In this manner, the clinician holds the handpiecehousing 16 of the handpiece assembly 60 with one hand and may holdeither the slap hammer 136 or the grip 148 portions and employssubstantially the energy generated by the ultrasonic transducer 14 fortissue effects. In another phase, the clinician may hold the grip 148with one hand and slideably move the slap hammer 136 axially in thedirection indicated by arrow 142 to impact the distal surface 144 of theweighted slap hammer 136 against the proximal surface 146 of theproximal stop 140. This action imparts a driving force or energy the endeffector 50. The slap hammer 136 may be manually operated either with orwithout the assistance of the ultrasonic vibrations. For example, theslap hammer 136 may be employed with the ultrasonic hand piece assembly60 either in a powered or unpowered state.

FIG. 6 is a cross-sectional view of one embodiment of an vibrationalsurgical instrument 170 taken along the longitudinal axis “L”. In theillustrated embodiment, the vibrational surgical instrument 170comprises an end effector 50 that is well-suited for effecting (e.g.,cutting, coagulating, drilling) musculoskeletal tissue comprising bones,muscles, joints, and the associated periarticular tissues such astendons, ligaments, cartilage, joints, and spinal discs. As previouslydiscussed, the end effector 50 may have a chisel like shape adapted tocut bone or may have a rounded end adapted to drill small holes in bone.The vibrational surgical instrument 170 comprises a distal end 122 and aproximal end 124 and defines a longitudinal axis “L”.

The proximal end 124 comprises a handpiece assembly 172. A housing 188contains a generator 174 to drive a rotating cam 176 comprising a lobe178. In the illustrated embodiment, the hand piece assembly 172 does notcomprise a piezoelectric transducer to generate the ultrasonicvibrations. The generator 174 generates longitudinal vibrationaldisplacement by mechanical action without the use of piezoelectrictransducers. In one embodiment, the generator 174 produces longitudinalmechanical vibrations of various predetermined frequencies by drivingthe cam 176 about a hub 175. The lobe 178 may be configured as anysuitable projecting part of the rotating cam 176 to strike ormechanically communicate with a surface 180 of a vibrationaltransmission waveguide 182 at one or more points on its circular path.The surface 180 has an area configured to receive vibratory energy inthe form of mechanical impacts. The lobe 178 imparts vibratory energyinto the vibrational transmission waveguide 182. The vibrationaltransmission waveguide 182 acts as a follower. This produces a smoothaxial oscillating motion in the vibrational transmission waveguide 182that makes contact with the lobe 178 via the surface 180. The lobe 178may be a simple rounded smooth projection to deliver pulses of power tothe surface 180 of the vibrational transmission waveguide 182. Inalternative embodiments, the lobe 178 may be an eccentric disc or othershape that produces a smooth oscillating motion in the vibrationaltransmission waveguide 182 follower which is a lever making contact withthe lobe 178. Accordingly, the lobe 178 translates the circular motionof the cam 176 to linear displacements creating longitudinal theoscillations or vibrations that are efficiently transferred to thedistal end 52 of the end effector 50 by the vibrational transmissionwaveguide 182. Accordingly, the distal end 52 of the end effector 50experiences longitudinal displacements to effect tissue. The generator174 may employ either an electric, hydraulic, or pneumatic motor todrive the cam 176 about the hub 175. Those skilled in the art willappreciate that a hydraulic motor uses a high pressure water jet to turna shaft coupled to the cam 176 about the hub 175.

The vibrational transmission waveguide 182 may be positioned inside ahandle portion or grip 184 over a sleeve 186. The vibrationaltransmission waveguide 182 may be retained within the grip 184 and maybe fixedly mounted by a ring or circumferential projection 190. Thecircumferential projection 190 may be formed integrally with the distalportion of the vibrational transmission waveguide 182 or may be fixedlymounted thereto. In principle, the vibrational transmission waveguide182 operates in a manner similar to the ultrasonic transmissionwaveguide 46 discussed in FIG. 1. The vibrational transmission waveguide182, however, may be tuned to amplify and transmit longitudinalvibrations at frequencies that may be suitably or practically achievedwith the rotating cam 176 and lobe 178 arrangement. Nevertheless, it iscontemplated that the vibrational transmission waveguide 182 may bedriven at ultrasonic frequencies. As previously discussed, a suitablevibrational frequency range may be about 20 Hz to 120 kHz and awell-suited vibrational frequency range may be about 30-70 kHz and oneexample operational vibrational frequency may be approximately 55.5 kHz.

The vibrational transmission waveguide 182 is positioned within thelongitudinal opening defined through the outer tube 150. The vibrationaltransmission waveguide 182 comprises a plurality of stabilizing siliconerings or compliant supports 56 positioned at a plurality of nodes. Thesilicone rings 56 dampen undesirable vibration and isolate theultrasonic energy from the outer tube 150 assuring the flow ofvibrational energy in a longitudinal direction to the distal end 52 ofthe end effector 50 with maximum efficiency.

In use, a clinician may employ the vibrational surgical instrument 170to effect musculoskeletal tissue. The end effector 50 is positioned atthe desired tissue treatment region within a patient. The clinicianholds the grip 184 portion and manipulates the end effector 50 to treatthe musculoskeletal tissue. The vibrations generated by the rotating cam176 and lobe 178 arrangement are efficiently transferred to the distalend 52 of the end effector 50 by the vibrational transmission waveguide182. Accordingly, the distal end 52 of the end effector 50 experienceslongitudinal displacements to assist the tissue effects of cutting,coagulating, drilling tissue. Accordingly, the vibrational surgicalinstrument 170 enables the clinician to perform tissue effects onmusculoskeletal tissue with more precision that may be achieved with aslap hammer alone or using an osteotome (e.g., bone chisel) and mallet.An osteotome is a wedge-like instrument used for cutting or marking boneoften called a chisel and is used by a clinician with a mallet.

FIG. 7 is a cross-sectional view of one embodiment of a vibrationalsurgical instrument 200 taken along the longitudinal axis “L”. In theillustrated embodiment, the vibrational surgical instrument 200comprises an end effector 50 that is well-suited for effecting (e.g.,cutting, coagulating, drilling) musculoskeletal tissue comprising bones,muscles, joints, and the associated periarticular tissues such astendons, ligaments, cartilage, joints, and spinal discs. As previouslydiscussed, the end effector 50 may have a chisel like shape adapted tocut bone or may have a rounded end adapted to drill small holes. Thevibrational surgical instrument 200 comprises a distal end 122 and aproximal end 124 and defines a longitudinal axis “L”.

The vibrational surgical instrument 200 comprises a flange or strikeplate 202 at the proximal end 124. The strike plate 202 defines astrikeable surface 203 having a flange area configured to receivevibratory energy in the form of mechanical impacts such as a mallet blowfrom an osteotome type mallet 204 and impart the resulting vibratoryenergy into the end effector 50. Striking the strike plate 202 with themallet 204 generates a suitable vibrational resonance that may besustained over time to mechanically displace the end effector 50 inaccordance with the mechanical vibrations. The vibrational surgicalinstrument 200 comprises a vibrational transmission waveguide 206positioned within an outer tubular member or outer tube 150. Thevibrational transmission waveguide 206 comprises a plurality ofstabilizing silicone rings or compliant supports 56 positioned at aplurality of nodes. The silicone rings 56 dampen undesirable vibrationand isolate the ultrasonic energy from a removable sheath 150 assuringthe flow of vibrational energy in a longitudinal direction to the distalend 52 of the end effector 50 with maximum efficiency.

The vibrational transmission waveguide 206 is positioned inside a handleportion or grip 208 over a sleeve 210 (e.g., bushing). The vibrationaltransmission waveguide 206 is retained within the grip 208 and isfixedly mounted by a ring or circumferential projection 212. Thecircumferential projection 212 may be formed integrally with the distalportion of the vibrational transmission waveguide 206 or may fixedlymounted thereto. In principle, the vibrational transmission waveguide206 operates in a manner similar to the ultrasonic transmissionwaveguide 46 discussed above. The vibrational transmission waveguide 206however may be tuned to amplify and transmit longitudinal vibrations atfrequencies more suitably achievable with the osteotome type mallet 204striking the strikeable surface 230 of the strike plate 202.

In use, a clinician may employ the vibrational surgical instrument 200to effect musculoskeletal tissue. The end effector 50 is positioned atthe desired tissue treatment region within a patient. The clinicianholds the grip 208 portion with one hand and manipulates the endeffector 50 to treat the musculoskeletal tissue. The vibrationsgenerated by striking the strike plate 202 are efficiently transferredto the distal end 52 of the end effector 50, which experienceslongitudinal displacements to assist in the tissue effect, to cut,coagulate, drill tissue. Accordingly, the vibrational surgicalinstrument 200 enables the clinician to perform tissue effects onmusculoskeletal tissue with more precision that with using a slap hammeralone or using a bone chisel or tuned osteotome.

FIG. 8 is a cross-sectional view of one embodiment of an ultrasonicinstrument 240 taken along the longitudinal axis “L”. In the illustratedembodiment, the ultrasonic instrument 240 comprises an end effector 50that is well-suited for effecting (e.g., cutting, coagulating, drilling)musculoskeletal tissue comprising bones, muscles, joints, and theassociated periarticular tissues such as tendons, ligaments, cartilage,joints, and spinal discs. As previously discussed, the end effector 50may have a chisel like shape adapted to cut bone or may have a roundedend adapted to drill small holes. The ultrasonic instrument 240comprises a distal end 122 and a proximal end 124 and defines alongitudinal axis “L”. The ultrasonic instrument 240 may be employed asan ultrasonic osteo-hammer to help drive cutting instruments and otherhardware such as “trial” devices into musculoskeletal tissue such asbone. In various other embodiments, however, the ultrasonic instrument240 may be employed in combination with an ultrasonic end effector 50comprising conventional ultrasonic blades for cutting, coagulating,and/or reshaping tissue. In the embodiment illustrated in FIG. 8, theultrasonic instrument 240 may be employed to drive the end effector 50into tissue or force distraction, e.g., separation of bony fragments orjoint surfaces of a limb, and also may be employed to remove instrumentsthat may be tightly wedged. The ultrasonic instrument 240 increasesefficiency and speed during a procedure while providing more accuracythat a manually operated osteotome.

The ultrasonic instrument 240 comprises an ultrasonic slide hammer 242at the proximal end 124. The ultrasonic slide hammer 242 is slideablymovable over a proximal shaft 244 between a first flange or proximalstop 246 and a second flange or distal stop 248 in the directionsindicated by arrows 290, 292. The ultrasonic slide hammer 242 comprisesan ultrasonic transducer 250, which is known as a “Langevin stack”, andgenerally includes a transduction portion 252, a first resonator orend-bell 254, and a second resonator or fore-bell 256, and ancillarycomponents. In the illustrated embodiment, the ultrasonic transducer 250is the moving mass of the ultrasonic slide hammer 242. The ultrasonictransducer 250 is preferably an integral number of one-half systemwavelengths (nλ/2) in length as previously discussed with reference tothe ultrasonic system 10 in FIG. 1. An acoustic assembly 251 is formedby the ultrasonic transducer 250, the proximal shaft 244, the proximalstop 246, and the distal stop 248. In the illustrated embodiment, thelength of the ultrasonic transducer 250 is λ/2 and the length of theproximal shaft 244 is at least 1λ as illustrated, with anti-nodesgenerally indicated at “A” (e.g., where axial displacement is usuallymaximal) being formed at the distal and proximal ends of the proximalshaft 244. The proximal shaft 244 may be made longer. Nevertheless, thelength of the proximal shaft 244 should be an integer multiple ofhalf-wavelengths (nλ/2) and should be at least one-half wavelength (λ/2)longer than the ultrasonic transducer 250. The length of the ultrasonicinstrument 240 from the distal end of the proximal shaft 244 to thedistal end 52 of the end effector 50 should be an integer multiple ofone-half system wavelengths (nλ/2). These relationships are explained inmore detail below.

The distal end of the end-bell 254 is connected to the proximal end ofthe transduction portion 252, and the proximal end of the fore-bell 256is connected to the distal end of the transduction portion 252. Thefore-bell 256 and the end-bell 254 have a length determined by a numberof variables, including the thickness of the transduction portion 252,the density and modulus of elasticity of the material used tomanufacture the end-bell 254 and the fore-bell 256, and the resonantfrequency of the ultrasonic transducer 250. The ultrasonic transducer250 creates impacts or vibrations at ultrasonic frequencies and impartsstress waves that are coupled to an ultrasonic transmission waveguide262 to advance (e.g., drive) or remove (e.g., retract) the ultrasonicinstrument 240. A distal surface of the fore-bell 256 acts a drivingplaten 288 when it is driven or coupled to a distal striking platen 258formed by the proximal surface of the distal stop 248. The surface ofthe distal striking platen 258 has an area configured to receivevibratory energy in the form of vibrations and impart the vibratoryenergy into the end effector 50. The surface of the driving platen 288is located at an anti-node “A”. When the driving platen 288 is coupledto the distal striking platen 258, ultrasonic vibrations generated bythe ultrasonic transducer 250 are coupled through the ultrasonictransmission waveguide 262 and create impacts to drive the ultrasonicinstrument 240 into tissue at the distal end 122 in the directionindicated by arrow 290. A proximal surface of the end-bell 254 acts as aremoving platen 286 when it is driven or coupled to a proximal strikingplaten 260 formed by the distal surface of the proximal stop 246. Thesurface of the distal striking platen 260 has an area configured toreceive vibratory energy in the form of vibrations and impart thevibratory energy into the proximal stop 246. The surface of the removingplaten 286 is located at an anti-node “A”. When the removing platen 286is coupled to the proximal striking platen 260, ultrasonic vibrationsgenerated by the ultrasonic transducer 250 are coupled into the proximalstop 246 and create impacts to retract the ultrasonic instrument 240 inthe proximal directions from the tissue in the direction indicated byarrow 292. A suitable vibrational frequency range for the ultrasonicslide hammer 242 may be about 20 Hz to 120 kHz and a well-suitedvibrational frequency range may be about 30-70 kHz and one exampleoperational vibrational frequency may be approximately 55.5 kHz. As ageneral rule, lower frequencies tend to provide more power capability.In one embodiment, the ultrasonic transducer 250 does not couple to theend effector 50, but rather creates a vibratory “jackhammer”.

Piezoelectric elements 264 may be fabricated from any suitable material,such as, for example, lead zirconate-titanate, lead meta-niobate, leadtitanate, or other piezoelectric crystal material. Each of positiveelectrodes 266, negative electrodes 268, and piezoelectric elements 264has a bore extending through the center. The positive and negativeelectrodes 266 and 268 are electrically coupled to wires 272 and 270,respectively. The wires 270, 272 are encased within a cable 274 andelectrically connectable to an ultrasonic signal generator 276.

The ultrasonic transducer 250 converts the electrical signal from theultrasonic signal generator 276 into mechanical energy that results inprimarily longitudinal vibratory motion of the ultrasonic transducer 250and the end effector 50 at ultrasonic frequencies. A suitable generatoris available as model number GEN04, from Ethicon Endo-Surgery, Inc.,Cincinnati, Ohio. When the acoustic assembly 251 is energized, avibratory motion standing wave is generated through the acousticassembly 251. The amplitude of the vibratory motion at any point alongthe acoustic assembly 251 may depend upon the location along theacoustic assembly 251 at which the vibratory motion is measured. Aminimum or zero crossing in the vibratory motion standing wave isgenerally referred to as a node (i.e., where motion is usually minimal),and an absolute value maximum or peak in the standing wave is generallyreferred to as an anti-node (i.e., where motion is usually maximal). Thedistance between an anti-node and its nearest node is one-quarterwavelength (λ/4).

The wires 270 and 272 transmit an electrical signal from the ultrasonicsignal generator 276 to the respective positive electrodes 268 and thenegative electrodes 266. The piezoelectric elements 264 are energized bythe electrical signal supplied from the ultrasonic signal generator 264in response to a foot switch 278 to produce an acoustic standing wave inthe acoustic assembly 251. The electrical signal causes disturbances inthe piezoelectric elements 264 in the form of repeated smalldisplacements resulting in large compression forces within the material.The repeated small displacements cause the piezoelectric elements 264 toexpand and contract in a continuous manner along the axis of the voltagegradient, producing longitudinal waves of ultrasonic energy. Theultrasonic energy is transmitted through the acoustic assembly 251 tothe end effector 50 via the ultrasonic transmission waveguide 262. Inorder for the acoustic assembly 251 to deliver energy to the endeffector 50, all components of the acoustic assembly 251 must beacoustically coupled to the end effector 50. In one mode of operation,the distal end 52 of the ultrasonic transducer 250 may be acousticallycoupled to the proximal surface 258 of the distal stop 248 and to theultrasonic transmission waveguide 262. In another mode of operation, theproximal end of the ultrasonic transducer 250 may be acousticallycoupled to the distal surface 260 of the proximal stop 246 and toultrasonic transmission waveguide 262 through the proximal shaft 244.

The components of the acoustic assembly 251 are preferably acousticallytuned such that the length of any assembly is an integral number ofone-half wavelengths (nλ/2), where the wavelength λ is the wavelength ofa pre-selected or operating longitudinal vibration drive frequency f_(d)of the acoustic assembly 251, and where n is any positive integer. It isalso contemplated that the acoustic assembly 251 may incorporate anysuitable arrangement of acoustic elements.

The ultrasonic end effector 50 may have a length substantially equal toan integral multiple of one-half system wavelengths (λ/2). The distalend 52 of the ultrasonic end effector 50 may be disposed near anantinode “A” in order to provide the maximum longitudinal excursion ofthe distal end 52. When the ultrasonic transducer 250 is energized andthe vibrations are coupled to the end effector 50 via the ultrasonictransmission waveguide 262, the distal end 52 of the ultrasonic endeffector 50 may be configured to move in the range of, for example,approximately 10 to 500 microns peak-to-peak, and preferably in therange of about 30 to 150 microns at a predetermined vibrationalfrequency.

The ultrasonic end effector 50 may be coupled to the ultrasonictransmission waveguide 262. In the illustrated embodiment, theultrasonic end effector 50, the ultrasonic transmission guide 262, theproximal and distal stops 246, 248, and the proximal shaft 244 areformed as a single unit construction from a material suitable fortransmission of ultrasonic energy such as, for example, Ti6Al4V (analloy of Titanium including Aluminum and Vanadium), Aluminum, StainlessSteel, or other known materials. Alternately, the ultrasonic endeffector 50 may be separable (and of differing composition) from theultrasonic transmission waveguide 262, and coupled by, for example, astud, weld, glue, quick connect, or other suitable known methods. Theultrasonic transmission waveguide 262 may have a length substantiallyequal to an integral number n of one-half system wavelengths (nλ/2), forexample. The ultrasonic transmission waveguide 262 may be preferablyfabricated from a solid core shaft constructed out of material thatpropagates ultrasonic energy efficiently, such as titanium alloy (i.e.,Ti-6Al-4V) or an aluminum alloy, for example. In the illustratedembodiment, the ultrasonic transmission waveguide 262 comprises aplurality of stabilizing silicone rings or compliant supports 56positioned at a plurality of nodes. The silicone rings 56 dampenundesirable vibration and isolate the ultrasonic energy from the outertube 150 assuring that the ultrasonic energy flows axially in alongitudinal direction “L” to the distal end 52 of the end effector 50with maximum efficiency.

In alternative embodiments, the distal end of the distal stop 248 may beconfigured with an attachment feature such as a threaded connection tocouple the ultrasonic transmission waveguide 262 or other ultrasonic(e.g., orthopedic) instruments with a stud. In other embodiments, thedistal end of the distal stop 248 may be configured with alongitudinally projecting attachment post to couple to the ultrasonictransmission waveguide 262 or other ultrasonic instruments thereto. Inother embodiments, the ultrasonic transmission waveguide 262 or otherultrasonic instruments may be attached to the distal end of the distalstop 248 by a weld, glue, quick connect, or other suitable knownmethods.

In use, a clinician can operate the ultrasonic instrument 240 in adriving mode and a retracting mode. In the illustrated embodiment, theultrasonic slide hammer 242 is configured with a cylindrical grip 294for the clinician to hold. In a driving mode, the ultrasonic slidehammer 242 is moved in the direction indicated by arrow 290 to drive theultrasonic instrument 240 into tissue. In a retracting mode, theultrasonic slide hammer 242 in the direction indicated by arrow 292 toretract the ultrasonic instrument 240. In alternative embodiments, theultrasonic slide hammer 242 may be configured with a pistol-like grip sothe clinician can hold the ultrasonic slide hammer 242 more-like a powerdrill, for example. When the driving platen 288 is forced in thedirection indicated by arrow 290 into the distal striking platen 258,the ultrasonic transducer 250 creates impacts that are coupled by theultrasonic transmission waveguide 262 to the end effector 50 to impartstress waves in the tissue being treated. Because the driving platen 288and the distal striking platen 258 are both located at anti-nodes “A” aclinician needs only to apply enough load to force the driving platen288 into the distal striking platen 258 together. At an anti-node “A”there is little vibrational stress so minimal vibrations are transferredto the hand of the clinician. The clinician applies a force until thedesired effect is achieved.

The ultrasonic instrument 240 may comprise an optional grip 280positioned distally beyond the proximal stop 248 over a proximal sleeve282. The grip 280 is fixedly mounted to the ultrasonic transmissionwaveguide 262 by a ring or circumferential projection 284. Thecircumferential projection 284 may be formed integrally with the distalportion of the ultrasonic transmission waveguide 262 or may fixedlymounted thereto. The grip 280 provides an additional handle for aclinician to hold during a procedure to help support and guide theultrasonic instrument 240.

FIG. 9 is a cross-sectional view of one embodiment of an ultrasonicinstrument 300 taken along the longitudinal axis “L”. In the illustratedembodiment, the ultrasonic instrument 300 comprises an end effector 50that is well-suited for effecting (e.g., cutting, coagulating, drilling)musculoskeletal tissue comprising bones, muscles, joints, and theassociated periarticular tissues such as tendons, ligaments, cartilage,joints, and spinal discs, as previously discussed. The ultrasonicinstrument 300 comprises a distal end 122 and a proximal end 124 anddefines a longitudinal axis “L”. The ultrasonic instrument 300 may beemployed as an ultrasonic osteo-hammer to help drive cutting instrumentsand other hardware such as “trial” devices into tissue. The ultrasonicinstrument 300 may be employed to drive into tissue or force distractionand also may be employed to remove instruments that may be tightlywedged. The ultrasonic instrument 300 increases efficiency and speedduring a procedure while providing more accuracy that a manuallyoperated osteotome.

The ultrasonic instrument 300 comprises an ultrasonic slide hammer 242at the proximal end 124 substantially as described with reference toFIG. 8. The ultrasonic slide hammer 242 is slideably movable over aproximal shaft 244 between a first flange or proximal stop 246 and asecond flange or distal stop 302 in the directions indicated by arrows290, 292. In the illustrated embodiment, the distal stop 302 has agenerally frustoconical shape and is tapered inwardly from a proximalend to a distal end to amplify the ultrasonic vibration amplitudegenerated by the ultrasonic transducer 250. As shown in the embodimentillustrated in FIG. 9, the conical transition occurs at a node “N”. Theultrasonic slide hammer 242 comprises an ultrasonic transducer 250, aspreviously discussed with reference to FIG. 8. In the illustratedembodiment, the ultrasonic transducer 250 is the moving mass of theultrasonic slide hammer 242. The ultrasonic transducer 250 is preferablyan integral number of one-half system wavelengths (nλ/2) in length aspreviously discussed with reference to the ultrasonic system 10 inFIG. 1. An acoustic assembly 306 is formed by the ultrasonic transducer250, the proximal shaft 244, and either one of the proximal stop 246 orthe distal stop 302. In the illustrated embodiment, the length of theultrasonic transducer 250 is λ/2 and the length of the proximal shaft244 is λ, with anti-nodes generally indicated at “A” (e.g., where axialdisplacement is usually maximal) being formed at the distal and proximalends of the proximal shaft 244. The length of the ultrasonic instrument300 from the distal end of the proximal shaft 244 to the distal end 52of the end effector 50 should be an integer multiple of one-half systemwavelengths (nλ/2). These relationships were explained in more detailabove with reference to FIG. 8.

As previously discussed, the ultrasonic transducer 250 creates impactsor vibrations at ultrasonic frequencies and imparts stress waves thatare coupled by an ultrasonic transmission waveguide 304 to advance(e.g., drive) or remove (e.g., retract) the ultrasonic instrument 300. Adistal driving platen 288 is driven or coupled to a distal strikingplaten 258 formed by the proximal surface of the distal stop 302 whenthe ultrasonic slide hammer 242 is moved in the direction indicated byarrow 290. The surface of the driving platen 288 is located at ananti-node “A”. When the driving platen 288 is coupled to the distalstriking platen 258, ultrasonic vibrations generated by the ultrasonictransducer 250 are coupled through the ultrasonic transmission waveguide304 and creates impacts to drive the ultrasonic instrument 300 intotissue at the distal end 122 in the direction indicated by arrow 290. Aproximal removing platen 286 is driven or coupled to a proximal strikingplaten 260 formed by the distal surface of the proximal stop 246 whenthe ultrasonic slide hammer 242 is moved in the direction indicated byarrow 292. The surface of the removing platen 286 is located at ananti-node “A”. When the removing platen 286 is coupled to the proximalstriking platen 260, ultrasonic vibrations generated by the ultrasonictransducer 250 are coupled into the proximal stop 246 and createsimpacts to retract the ultrasonic instrument 300 in the proximaldirection from the tissue in the direction indicated by arrow 292. Aspreviously discussed, the distal stop 302 amplifies the amplitude of theultrasonic vibrations generated by the ultrasonic transducer 250. Asuitable vibrational frequency range for the ultrasonic slide hammer 242may be about 20 Hz to 120 kHz and a well-suited vibrational frequencyrange may be about 30-70 kHz and one example operational vibrationalfrequency may be approximately 55.5 kHz. As a general rule, lowerfrequencies tend to provide more power capability.

The ultrasonic transducer 250 converts the electrical signal from theultrasonic signal generator 276 into mechanical energy that results inprimarily longitudinal vibratory motion of the ultrasonic transducer 250and the end effector 50 at ultrasonic frequencies. When the acousticassembly 306 is energized, a vibratory motion standing wave is generatedthrough the acoustic assembly 306. The amplitude of the vibratory motionat any point along the acoustic assembly 306 may depend upon thelocation along the acoustic assembly 306 at which the vibratory motionis measured. A minimum or zero crossing in the vibratory motion standingwave is generally referred to as a node (i.e., where motion is usuallyminimal), and an absolute value maximum or peak in the standing wave isgenerally referred to as an anti-node (i.e., where motion is usuallymaximal). The distance between an anti-node and its nearest node isone-quarter wavelength (λ/4).

The ultrasonic transducer 250 is energized by the electrical signalsupplied from the ultrasonic signal generator 264 in response to a footswitch 278 to produce an acoustic standing wave in the acoustic assembly306. The ultrasonic energy is transmitted through the acoustic assembly306 to the end effector 50 via an ultrasonic transmission waveguide 304.In order for the acoustic assembly 306 to deliver energy to the endeffector 50, all components of the acoustic assembly 306 must beacoustically coupled to the end effector 50. In one mode of operation,the distal end of the ultrasonic transducer 250 may be acousticallycoupled to the distal striking platen 258, amplified by the distal stop302 element, and to the ultrasonic transmission waveguide 304. Inanother mode of operation, the proximal end of the ultrasonic transducer250 may be acoustically coupled to the proximal striking platen 260through the ultrasonic transmission waveguide 304 and through theproximal shaft 244.

The components of the acoustic assembly 306 are preferably acousticallytuned such that the length of any assembly is an integral number ofone-half wavelengths (nλ/2), where the wavelength λ is the wavelength ofa pre-selected or operating longitudinal vibration drive frequency f_(d)of the acoustic assembly 306, and where n is any positive integer. It isalso contemplated that the acoustic assembly 306 may incorporate anysuitable arrangement of acoustic elements.

The ultrasonic end effector 50 may have a length substantially equal toan integral multiple of one-half system wavelengths (λ/2). The distalend 52 of the ultrasonic end effector 50 may be disposed near anantinode in order to provide the maximum longitudinal excursion of thedistal end. When the ultrasonic transducer 250 is energized and thevibrations are coupled to the end effector 50 via the ultrasonictransmission waveguide 304, the distal end 52 of the ultrasonic endeffector 50 may be configured to move in the range of, for example,approximately 10 to 500 microns peak-to-peak, and preferably in therange of about 30 to 150 microns at a predetermined vibrationalfrequency.

The ultrasonic end effector 50 may be coupled to the ultrasonictransmission waveguide 304. In the illustrated embodiment, theultrasonic end effector 50, the ultrasonic transmission guide 304, theproximal and distal stops 246, 302, and the proximal shaft 244 areformed as a single unit construction from a material suitable fortransmission of ultrasonic energy such as, for example, Ti6Al4V (analloy of Titanium including Aluminum and Vanadium), Aluminum, StainlessSteel, or other known materials. Alternately, the ultrasonic endeffector 50 may be separable (and of differing composition) from theultrasonic transmission waveguide 304, and coupled by, for example, astud, weld, glue, quick connect, or other suitable known methods. Theultrasonic transmission waveguide 304 may have a length substantiallyequal to an integral number n of one-half system wavelengths (nλ/2), forexample. The ultrasonic transmission waveguide 304 may be preferablyfabricated from a solid core shaft constructed out of material thatpropagates ultrasonic energy efficiently, such as titanium alloy (i.e.,Ti-6Al-4V) or an aluminum alloy, for example. In the illustratedembodiment, the ultrasonic transmission waveguide 304 comprises aplurality of stabilizing silicone rings or compliant supports 56positioned at a plurality of nodes. The silicone rings 56 dampenundesirable vibration and isolate the ultrasonic energy from a removablesheath or outer tube 150 assuring the flow of ultrasonic energy axiallyin a longitudinal direction “L” to the distal end 52 of the end effector50 with maximum efficiency.

In alternative embodiments, the distal end of the distal stop 302 may beconfigured with an attachment feature such as a threaded connection tocouple the ultrasonic transmission waveguide 304 or other ultrasonic(e.g., orthopedic) instruments with a stud. In other embodiments, thedistal end of the distal stop 302 may be configured with alongitudinally projecting attachment post to couple to the ultrasonictransmission waveguide 304 or other ultrasonic instruments thereto. Inother embodiments, the ultrasonic transmission waveguide 304 or otherultrasonic instruments may be attached to the distal end of the distalstop 302 by a weld, glue, quick connect, or other suitable knownmethods.

In use, a clinician can operate the ultrasonic instrument 300 in asubstantially similar manner as previously described with reference toFIG. 8. In the illustrated embodiment, the ultrasonic slide hammer 242is configured with a cylindrical grip 294 so the clinician can hold theultrasonic slide hammer 242 while moving it. To drive the ultrasonicinstrument 300, the clinician moves the ultrasonic slide hammer 242 inthe direction indicated by arrow 290. To retract the ultrasonicinstrument 300, the clinician moves the slide hammer 242 in thedirection indicated by arrow 292. In alternative embodiments, theultrasonic slide hammer 242 may be configured with a pistol-like grip sothe clinician can hold the ultrasonic slide hammer 242 more-like a powerdrill, for example. When the driving platen 288 is forced in thedirection indicated by arrow 290 into the distal striking platen 258,the ultrasonic transducer 250 creates impacts that are coupled by theultrasonic transmission waveguide 304 to the end effector 50 to impartstress waves in the tissue being treated. Because the driving platen 288and the distal striking platen 258 are both located at anti-nodes “A” aclinician needs only to apply enough load to force the driving platen288 into the distal striking platen 258 together. At an anti-node “A”there is little vibrational stress so minimal vibrations are transferredto the hand of the clinician. The clinician applies the force until thedesired effect is achieved.

With reference to the ultrasonic instruments 240, 300 illustrated inFIGS. 8 and 9, in order to drive into tissue, the distal end 52 of theend effector 50 must overcome the failure limit of the tissue. In asimple model, this may be represented as the tissue reaction force andis a measure of the force necessary at the distal end 52 of the endeffector 50 acting normal to the tissue (e.g., bone) to penetrate thetissue. The ultrasonic force required at the tissue surface to overcomethe failure limit of the tissue may be expressed in simplified form asthe tissue reaction force F_(t):F _(t) =k·x+c·x+d·x ²  (1)

Where

k=is the elastic component of the tissue;

c=the frictional component of the tissue; and

d=the hydraulic drag component of the tissue.

FIG. 10 illustrates a side view of one embodiment of an ultrasonicinstrument 310 comprising an impact zone. In the illustrated embodiment,the ultrasonic instrument 310 extends longitudinally along axis “L”between a distal end 122 and a proximal end 124. In one embodiment, theultrasonic instrument 310 comprises an ultrasonic hand piece assembly312. Ultrasonically, the hand piece assembly 312 is substantiallysimilar to and operates in substantially the same manner as theultrasonic handpiece assembly 60 described in FIG. 1. The ultrasonicinstrument 310 comprises a housing 314, a transduction portion 18, andan acoustic assembly 24 portion, as previously discussed with referenceto FIG. 1. In one embodiment, the housing 314 comprises a substantiallycircular cross-section (not shown). The ultrasonic instrument 310comprises the outer sheath 58 containing an ultrasonic transmissionwaveguide 46 (as previously discussed in FIG. 1) coupled to the endeffector 50. In the illustrated embodiment, the end effector 50 has achisel shape. A power cable 42 couples the ultrasonic handpiece assembly312 to an ultrasonic generator (e.g., ultrasonic generator 12 shown inFIG. 1).

In one embodiment, the ultrasonic instrument 310 comprises a strikeplate assembly 316. The strike plate assembly 316 comprises a flange orstrike plate 318 defining a strikeable surface 320 having a flange areaconfigured to receive or accommodate a mechanical impact and impartenergy into the end effector 50 when the hand piece assembly 312 is in apowered or an unpowered state. The mechanical impact or strike may bedelivered manually or with an osteotome mallet, for example. The strikeplate 318 is suitable to receive a typical blow or strike from anosteotome mallet (e.g., similar to the mallet 204 shown in FIG. 7) atthe strikeable surface 320 without damaging the ultrasonic hand pieceassembly 312. In the illustrated embodiment, the strike plate assembly316 comprises multiple longitudinally extending elongate support members322 rigidly coupled to the strike plate 318 at a proximal end andfixedly coupled to the housing 314 at a distal end. In one embodiment,the housing 314 and the strike plate assembly 318 may be formed as asingle unitary piece. In alternative embodiments, the housing 314 andthe strike plate assembly 318 may be attached, coupled, or joined by,for example, stud, weld, glue, quick connect, or other suitable knownmethods.

In use, a clinician may employ the ultrasonic instrument 310 in apowered state using the ultrasonic vibrations generated by thetransduction portion 18 to cut and coagulate relatively softmusculoskeletal tissue using the chisel shaped end effector 50. With theultrasonic instrument 310 in a powered or an unpowered state, theclinician can employ an osteotome mallet to strike the strikeablesurface 320 to chisel relatively hard musculoskeletal tissue such asbone.

FIG. 11 illustrates a side view of one embodiment of an ultrasonicinstrument 330 comprising an impact zone. In the illustrated embodiment,the ultrasonic instrument 330 extends longitudinally along axis “L”between a distal end 122 and a proximal end 124. In one embodiment, theultrasonic instrument 330 comprises an ultrasonic hand piece assembly332. Ultrasonically, the hand piece assembly 332 is substantiallysimilar to and operates in substantially the same manner as thehandpiece assembly 60 described in FIG. 1. The ultrasonic instrument 330comprises a housing 334, a transduction portion 18, and an acousticassembly 24 portion, as previously discussed with reference to FIG. 1.In one embodiment, the housing 334 comprises a substantially circularcross-section (not shown). The ultrasonic instrument 330 comprises thesheath 58 containing the ultrasonic transmission waveguide 46 therein(as previously discussed in FIG. 1) coupled to the end effector 50. Inthe illustrated embodiment, the end effector 50 has a chisel shape. Apower cable 42 couples the ultrasonic handpiece assembly 332 to anultrasonic generator (e.g., ultrasonic generator 12 shown in FIG. 1).

In one embodiment, the ultrasonic instrument 330 comprises a strikeplate assembly 336. The strike plate assembly 336 comprises a flange orstrike plate 338 defining a strikeable surface 340 having a flange areaconfigured to receive or accommodate a mechanical impact and impartenergy into the end effector 50 when the ultrasonic hand piece assembly332 is in a powered or an unpowered state. The mechanical impact orstrike may be delivered manually or with an osteotome mallet, forexample. The strike plate 338 is suitable to receive a typical blow orstrike from an osteotome mallet (e.g., similar to the mallet 204 shownin FIG. 7) at the strikeable surface 330 without damaging the ultrasonichand piece assembly 332. In the illustrated embodiment, the strike plateassembly 336 comprises one or more longitudinally extending elongatesupport members 342 and a transverse compression member 344 to removablycouple the strike plate assembly 336 to the housing 334. In oneembodiment, the transverse compression member 344 may be configured as aradially assembled “C” or “U” shaped compression member. The transversecompression member 344 may be radially assembled on the groove 346 byslidingly pressing the transverse compression member 344 in thedirection indicated by arrow 350 to engage and compress the groove 346formed on the housing 334. The transverse compression member 344 may bereadily removed by applying a force in the direction indicated by arrow348. The transverse compression member 344 may be configured to compressthe groove 346 with a force suitable to withstand strikes against thestrikeable surface 340 while it is engaged. In one embodiment, thegroove 346 may be a groove extending substantially around acircumferential portion or circular cross-sectional portion of thehousing 334.

As previously discussed with reference to FIG. 10, in use, a clinicianmay employ the ultrasonic instrument 330 in a powered state using theultrasonic vibrations generated by the transduction portion 18 to cutand coagulate relatively soft musculoskeletal tissue using the chiselshaped end effector 50. With the ultrasonic instrument 330 in a poweredor an unpowered state, the clinician can employ an osteotome mallet tostrike the strikeable surface 340 to chisel relatively hardmusculoskeletal tissue such as bone.

FIG. 12 illustrates a side view of one embodiment of an ultrasonicinstrument 360 comprising an impact zone. In the illustrated embodiment,the ultrasonic instrument 360 extends longitudinally along axis “L”between a distal end 122 and a proximal end 124. In one embodiment, theultrasonic instrument 360 comprises an ultrasonic hand piece assembly362. Ultrasonically, the hand piece assembly 362 is substantiallysimilar to and operates in substantially the same manner as thehandpiece assembly 60 described in FIG. 1. The ultrasonic instrument 360comprises a housing 364, a transduction portion 18, and an acousticassembly 24 portion, as previously discussed with reference to FIG. 1.In one embodiment, the housing 364 comprises a substantially circularcross-section (not shown). The ultrasonic instrument 360 comprises thesheath 58 containing the ultrasonic transmission waveguide 46 therein(as previously discussed in FIG. 1) coupled to the end effector 50. Inthe illustrated embodiment, the end effector 50 has a chisel shape. Apower cable 42 couples the ultrasonic handpiece assembly 362 to anultrasonic generator (e.g., ultrasonic generator 12 shown in FIG. 1).

In one embodiment, the ultrasonic instrument 360 comprises a strikeplate assembly 366. The strike plate assembly 366 comprises a flange orstrike plate 368 defining a strikeable surface 370 having a flange areaconfigured to receive or accommodate a mechanical impact and impartenergy into the end effector 50 when the hand piece assembly 362 is in apowered or an unpowered state. The mechanical impact or strike may bedelivered manually or with an osteotome mallet, for example. The strikeplate 368 is suitable to receive a typical blow or strike from anosteotome mallet (e.g., similar to the mallet 204 shown in FIG. 7) atthe strikeable surface 370 without damaging the ultrasonic hand pieceassembly 362. In the illustrated embodiment, the strike plate assembly366 comprises one or more longitudinally extending elongate supportmembers 372 a threaded connection 375. The threaded connection 375 isformed of internal female threaded portion 374 to engage a correspondingexternal male threaded portion 376 formed circumferentially around acircular cross-sectional portion of the housing 364. The strike plateassembly 366 may be engaged with the housing 364 by screwing the femalethreaded portion 374 over the male threaded portion 376. A stop 378 isrigidly attached or formed integrally with the housing 364 to contactdistal wall portions 380 of the support members 372. The strike plate368 comprises a sleeve 382 extending longitudinally from a proximal endto a distal end. The sleeve 382 comprises a flange 390 at a distal endto engage a compression spring element 384 positioned within the sleeve382. The proximal end 386 of the support member 372 comprises a flange388 formed to engage the proximal end of the compression spring element384. The compression spring element 384 is positioned around theproximal end 386 of the support member 372. The proximal end of thestrike plate 368 also comprises a ball 394 and a compression springelement 396 configured to engage and compress the surface of the ball394 to retain the strike plate 386 in position.

As previously discussed with reference to FIGS. 10 and 11, in use, aclinician may employ the ultrasonic instrument 360 in a powered stateusing the ultrasonic vibrations generated by the transduction portion 18to cut and coagulate relatively soft musculoskeletal tissue using thechisel shaped end effector 50. With the ultrasonic instrument 360 in apowered or an unpowered state, the clinician can employ an osteotomemallet to strike the strikeable surface 370 to chisel relatively hardmusculoskeletal tissue such as bone.

FIG. 13 illustrates a side view of one embodiment of an ultrasonicinstrument 400 comprising an impact zone. In the illustrated embodiment,the ultrasonic instrument 400 extends longitudinally along axis “L”between a distal end 122 and a proximal end 124. In one embodiment, theultrasonic instrument 400 comprises an ultrasonic hand piece assembly402. Ultrasonically, the hand piece assembly 402 is substantiallysimilar to and operates in substantially the same manner as thehandpiece assembly 60 described in FIG. 1. The ultrasonic instrument 400comprises a housing 404, a transduction portion 18, and an acousticassembly 24 portion, as previously discussed with reference to FIG. 1.In one embodiment, the housing 404 comprises a substantiallycircumferential cross-section (not shown). The ultrasonic instrument 400comprises the sheath 58 containing the ultrasonic transmission waveguide46 therein (as previously discussed in FIG. 1) coupled to the endeffector 50. In the illustrated embodiment, the end effector 50 has achisel shape. A power cord 42 couples the ultrasonic handpiece assembly402 to an ultrasonic generator (e.g., ultrasonic generator 12 shown inFIG. 1).

In one embodiment, the ultrasonic instrument 400 comprises a strikeplate assembly 406. The strike plate assembly 406 comprises a flange orstrike plate 408 defining a strikeable surface 410 having a flange areaconfigured to receive or accommodate a blow from a slide (slap) hammer414. The slide hammer 414 has an opening extending longitudinallytherethrough. The slide hammer 420 comprises a striking surface 422 at adistal end suitable to impart a blow to or strike the strikeable surface410. A blow from the slide hammer 414 imparts energy into the endeffector 50 when the hand piece assembly 402 is in a powered or anunpowered state. The strike plate 408 is suitable to receive a typicalblow or strike from the slide hammer 414 at the strikeable surface 410without damaging the ultrasonic hand piece assembly 402. In theillustrated embodiment, the strike plate assembly 406 comprises one ormore longitudinally extending elongate support members 412 rigidlyattached to the housing 404. The strike plate 408 is formed with a shaft416 protruding from a distal end to a proximal end. The proximal end ofthe shaft 416 comprises a flange 418. The slide (slap) hammer 414 isslideably movable axially on the shaft 416 in the direction indicated byarrow 420.

As previously discussed with reference to FIGS. 10-12, in use, aclinician may employ the ultrasonic instrument 400 in a powered stateusing the ultrasonic vibrations generated by the transduction portion 18to cut and coagulate relatively soft musculoskeletal tissue using thechisel shaped end effector 50. With the ultrasonic instrument 400 in apowered or an unpowered state, the clinician may strike the strikeablesurface 410 manually or may employ an osteotome mallet to chiselrelatively hard musculoskeletal tissue such as bone.

FIGS. 14-17 illustrate one embodiment of an ultrasonic instrument 450comprising an end effector 452 at a distal end 122. The ultrasonicinstrument 450 extends longitudinally along axis “L” between a distalend 122 and a proximal end 124. The end effector 452 comprises anon-vibrating clamp jaw 454 and an ultrasonic blade 456. In theembodiments illustrated in FIGS. 14-17, the clamp jaw 454 is pivotallymounted to pivot point 472 and is rotatable from a distal end to aproximal end as shown by arrow 458 to an open folded back position thatleaves the ultrasonic blade 456 exposed for reshaping and coagulatingtissue. The clamp jaw 454 is rotatable up to about 180° such that eitherin the open or the closed position, the clamp jaw 454 is substantiallyaligned with the longitudinal axis so as to be in line or in parallelwith the longitudinal axis. The clamp jaw 454 is rotatable from a distalend to a proximal end as shown by arrow 459 to a closed position forsqueezing the tissue between the blade 456 and the clamp jaw 454 againsta side of the blade 456, to use the shearing action of the vibration toenhance tissue cutting/coagulating effects. FIG. 14 is a sideperspective view of one embodiment of the ultrasonic instrument 450 withthe clamp jaw 454 in a closed position. FIGS. 15 and 16 are sideperspective views of the ultrasonic instrument 450 with the clamp jaw454 in partially open positions. FIG. 17 is side perspective view of theultrasonic instrument 450 with the clamp arm assembly in a closedposition.

With reference now to FIGS. 14-17, the ultrasonic instrument 450comprises an ultrasonic hand piece assembly 464. Ultrasonically, thehand piece assembly 464 is substantially similar to and operates insubstantially the same manner as the ultrasonic handpiece assembly 60described in FIG. 1. Accordingly, the ultrasonic hand piece assembly 464also comprises a transduction portion 18 and an acoustic assembly 24portion, as previously discussed with reference to FIG. 1. Theultrasonic instrument 450 comprises an outer tubular member or outertube 462 that extends from the handpiece assembly 464 to a proximal endof the end effector 452. The outer tube 462 has a substantially circularcross-section and a longitudinal opening or aperture 466 to receive theclamp jaw 454 in its retracted or folded back position. An inneractuator tubular member or inner tube 468 extends longitudinally withinthe outer tube 462. The inner tube 468 has an opening extendinglongitudinally therethrough. The outer tube 462 and the inner tube 468may be fabricated from stainless steel. It will be recognized that theouter tube 462 may be constructed from any suitable material and mayhave any suitable cross-sectional shape. The end-effector 452 isconfigured to perform various tasks, such as, for example, graspingtissue, cutting tissue and the like. It is contemplated that theend-effector 452 may be formed in any suitable configuration.

As previously discussed, the end-effector 452 comprises a non-vibratingclamp jaw 454 and an ultrasonic blade 456. A tissue engaging portion ofthe clamp arm assembly 454 comprises a clamp pad 470. The non-vibratingclamp jaw 454 is to grip tissue or compress tissue against theultrasonic blade 456, for example.

The ultrasonic blade 456 may comprise a chisel shape and is suitable tocut and coagulate relatively soft musculoskeletal tissue and to chiselor drill relatively hard musculoskeletal tissue such as bone.Nevertheless, the ultrasonic blade 456 may be employed in various othertherapeutic procedures. In one embodiment, the ultrasonic blade 456 maycomprise a cutting chisel edge at a distal portion. The ultrasonic blade456 is coupled to an ultrasonic transmission waveguide positioned withinthe outer tube 462.

The clamp jaw 454 is preferably pivotally mounted to the distal end ofthe outer tube 462 at pivot point 472 such that the clamp jaw 454 canrotate in the in an arcuate direction shown by arrows 458, 459. A pivotpin 474 is inserted through the pivot point 472. The distal end of theouter tube 462 comprises projections 476A and 476B that definecorresponding holes 478A and 478B (not shown) to receive the pivot pin474. The pivot pin 474 may be retained within the holes 478A, B in anysuitable configuration. The inner tube 468 opening contains an actuatorrod 490 that is mounted to a proximal end of the clamp jaw 454. When theactuator rod 490 is moved axially from the proximal end to the distalend in the direction indicated by arrow 482 the actuator rod 490 drivesthe clamp arm assembly to rotate about the pivot point 472 in thedirection indicated by arrow 458 to its open position. A longitudinalchannel 486 formed on a top surface of the clamp jaw 454 receives alongitudinal portion of the inner tube 468 therein when the clamp jaw454 is in the open position. The axially moveable actuator rod 490 maybe moved in any suitable manner and in one embodiment may be controlledby switch 480. When the actuator rod 490 is moved axially from thedistal end to the proximal end in the direction indicated by arrow 484the actuator rod 490 drives the clamp jaw 454 to rotate about the pivotpoint 472 in the direction indicated by arrow 459 to its closed orclamping position.

The clamp pad 470 is attached to the clamp jaw 454 and is for squeezingtissue between the ultrasonic blade 456 and the clamp jaw 454. The clamppad 470 may be mounted to the clamp jaw 454 by an adhesive, orpreferably by a mechanical fastening arrangement. Serrations 488 may beformed in the clamping surfaces of the clamp pad 470 and extendperpendicular to the axis of the ultrasonic blade 456 to allow tissue tobe grasped, manipulated, coagulated and cut without slipping between theclamp jaw 454 and the ultrasonic blade 456.

The clamp pad 470 may be formed of a polymeric or other compliantmaterial and engages the ultrasonic blade 456 when the clamp jaw 454 isin its closed position. Preferably, the clamp pad 470 is formed of amaterial having a low coefficient of friction but which has substantialrigidity to provide tissue-grasping capability, such as, for example,TEFLON®, a trademark name of E.I. Du Pont de Nemours and Company for thepolymer polytetraflouroethylene (PTFE). The clamp pad 470 may be formedof other materials, such as, polyimide materials and/or other filledmaterials, for example, graphite or TEFLON filled polyimide materials.One example of a polyimide material may be VESPEL®, a trademark name ofE.I. Du Pont de Nemours and Company. Polyimide provides a uniquecombination of the physical properties of plastics, metals, andceramics, for example. In one embodiment, the clamp pad 470 may beformed of multiple components and multiple materials. For example, theclamp pad 470 may comprise one component formed of TEFLON and anothercomponent formed of polyimide. The clamp pad 470 may comprise a basematerial and at least two filler materials to allow the base materialand the at-least-two filler materials to be chosen with a differenthardness, stiffness, lubricity, dynamic coefficient of friction, heattransfer coefficient, abradability, heat deflection temperature, and/ormelt temperature to improve the wearability of the clamp pad 470, whichis important when high clamping forces are employed because the clamppad 470 wears faster at higher clamping forces than at lower clampingforces. For example, a 15% graphite-filled, 30% PTFE-filled polyimideclamp pad 470 may provide substantially the same or better wear with a4.5 pound clamping force as a 100% polytetrafluoroethylene clamp padprovides with a 1.5 pound clamping force. The advantage of a 15%graphite-filled, 30% PTFE-filled polyimide clamp pad 470 is increasedheat resistance, which improves the overall wear resistance of the clamppad 470. This polyimide-composite clamp pad has a useful heat resistanceup about 800° F. to about 1200° F., as compared to a useful heatresistance up to about 660° F. of a PTFE clamp pad. Alternatively, othermaterials may be useful for a portion of the clamp pad 470, such asceramics, metals, glasses and graphite.

In alternative embodiments, the clamp jaw 454 may be configured toretract rather than to fold back. In one embodiment, the ultrasonicblade 456 also may be configured to retract in any suitable manner.

FIGS. 18-20 illustrate one embodiment of an end effector that may beemployed with the ultrasonic instrument 450 discussed in FIGS. 14-17. Inthe illustrated embodiment, the ultrasonic instrument 450 adapted andconfigured with the end effector 502 illustrated in FIGS. 18-20 is showngenerally as ultrasonic instrument 500. One embodiment of the ultrasonicinstrument 500 comprises the end effector 502 at a distal end 122. Theultrasonic instrument 500 extends longitudinally along axis “L” betweena distal end 122 and a proximal end 124. The end effector 502 comprisesa non-vibrating clamp jaw 504 and the ultrasonic blade 456. The clampjaw 504 provides an increased mechanical advantage over the clamp jaw454 of the end effector 452 shown in FIGS. 14-17. FIG. 18 is a topperspective view of one embodiment of the end effector 502 with theclamp arm assembly 504 in a closed position. FIG. 19 is a topperspective view of one embodiment of the end effector 502 with theclamp arm assembly 504 in an open position. FIG. 20 is an exploded viewof one embodiment of the end effector 502 with the clamp jaw 504 in anopen position.

With reference to FIGS. 18-20, the clamp jaw 504 is pivotally mounted ata pivot point 506 and is rotatable from a distal end to a proximal endas shown by arrow 458 to an open position that leaves the ultrasonicblade 456 exposed for reshaping and coagulating tissue. The clamp jaw504 is rotatable from a distal end to a proximal end as shown by arrow459 to a closed position for squeezing tissue between the blade 456 andthe clamp jaw 504 against a side of the blade 456, to use the shearingaction of the vibration to enhance tissue cutting/coagulating effects.The clamp jaw 504 comprises the clamp pad 470 configured with serrations488 formed thereon that extend perpendicular to the axis “L” of theultrasonic blade 456. The serrations 488 allow tissue to be grasped,manipulated, coagulated, and cut without slipping between the clamp jaw504 and the ultrasonic blade 456.

The ultrasonic instrument 500 comprises the outer tube 462. Aspreviously discussed, the outer tube 462 has a substantially circularcross-section and the longitudinal opening or aperture 466 to receivethe clamp jaw 504 in its retracted or folded back open position. Theouter tube 462 is configured to receive a first inner tube 518comprising a “D” shaped cross-section and defines an aperture 520therein to receive a distal portion of an elongated member 512. Theelongated member 512 comprises a pivot base member 515 and a channel514. The channel 514 is configured to receive an actuator rod 516. Theouter tube 462 contains a second inner tube 522 configured to receive anultrasonic transmission waveguide 457 portion of the blade 456.

The pivot point 506 is provided at the distal end of the elongatedmember 512. The clamp jaw 504 is pivotally mounted to the pivot point506 by a pivot pin 508 that is received through a first hole 510A, asecond hole 510B, and a third hole 510C. The clamp jaw 504 is coupled tothe actuator rod 516 with a first link 532A and a second link 532B. Thefirst and second links 532A, B are coupled to the clamp jaw 504 with pin534 received through a first hole 528B formed at a distal end of thefirst link 532A, a second hole 530B formed at a distal end of the secondlink 532B, and a slot 536 formed in the clamp jaw 504. The slot 536 isformed at an angle to the longitudinal axis “L” to enable the pin 534some freedom of motion within the slot 536 during the rotation of theclamp jaw 504. The first and second links 532A, B are coupled to theactuator rod 516 with a pin 526 received through a first hole 528Aformed at a proximal end of the first link 532A, a second hole 530Aformed at a proximal end of the second link 532B, and a third hole 540formed at a distal end 524 of the actuator rod 516.

FIGS. 21-24 illustrate the clamp jaw 504 transitioning from an openposition in FIG. 21 to a closed position in FIG. 24 and intermediatepositions in FIGS. 22 and 23. As shown, when the actuator rod 516 isadvanced in the direction indicated by arrow 482, an advancing force isapplied at the proximal ends of the first and second links 532A, B andthe clamp jaw 504 is pivoted in a direction indicated by arrow 459 aboutpivot point 506 into the clamp jaw 504 closed position shown in FIG. 18.The clamp pad 470 now bears against the blade 456. When the actuator rod516 is retracted in the direction indicated by arrow 484, a retractingforce is applied at the proximal ends of the first and second links532A, B and the clamp jaw 504 is pivoted in a direction indicated byarrow 458 about the pivot point 506 into the clamp jaw 504 open positionillustrated in FIG. 19.

FIGS. 25 and 26 illustrate one embodiment of an end effector 552 thatmay be employed with the ultrasonic instrument 450 discussed in FIGS.14-17. The ultrasonic instrument 450 adapted and configured with the endeffector 552 illustrated in FIGS. 25 and 26 is generally referred to asultrasonic instrument 550. One embodiment of the ultrasonic instrument550 comprises an end effector 552 at a distal end 122. The ultrasonicinstrument 550 extends longitudinally along axis “L” between a distalend 122 and a proximal end 124. The end effector 552 comprises anon-vibrating clamp jaw 504 and an ultrasonic blade 556. The clamp jaw504 provides an increased mechanical advantage over the clamp jaw 454 ofthe end effector 452 shown in FIGS. 14-17. FIG. 25 is a top perspectiveview of one embodiment of the end effector 552 with the clamp armassembly 504 in an open position. FIG. 26 is an exploded view of oneembodiment of the end effector 552 with the clamp jaw 504 in an openposition.

With reference to FIGS. 25 and 26, the end effector 552 comprises theclamp jaw 504 pivotally mounted at the pivot point 506 as previouslydescribed with respect to FIGS. 18-24. The end effector 552 comprises anultrasonic blade 556 having a broad generally flat top surface 558 and asmooth generally round bottom surface 560 and is well-suited forcoagulation and tissue reshaping applications. The broad generally flattop surface of the blade 556 is substantially wide and thin relative tothe width and is well suited for removing muscle tissue from bone andmay be referred to as an ultrasonic elevator blade.

The ultrasonic instrument 550 comprises the outer tube 462. Aspreviously discussed, the outer tube 462 has a substantially circularcross-section and defines a longitudinal opening or aperture 466 toreceive the clamp jaw 504 in its retracted or folded back open position.The outer tube 462 is configured to receive an inner tube 562 comprisinga circular cross-section with a wall 554 defining a first aperture 566to receive the elongated member 512 and a second aperture to receive anultrasonic transmission waveguide portion 557 of the blade 556. Theelongate member 512 comprises a pivot base member 515 and a channel 514.The channel 514 is configured to receive an actuator rod 516.

The pivot point 506 is formed at a distal end of the elongated member512. The clamp jaw 504 is pivotally mounted to the pivot point 506 bythe pivot pin 508 that is received through a first hole 510A, a secondhole 510B, and a third hole 510C. The clamp jaw 504 is coupled to theactuator rod 516 with a first link 532A and a second link 532B. Thefirst and second links 532A, B are coupled to the clamp jaw 504 with pin534 received through a first hole 528B formed at a distal end of thefirst link 532A, a second hole 530B formed at a distal end of the secondlink 532B, and a slot 536 formed in the clamp jaw 504. The slot 536 isformed at an angle to the longitudinal axis “L” to enable the pin 534some freedom of motion within the slot 536 as the clamp law 504 isrotated. The first and second links 532A, B are coupled to the actuatorrod 516 with a pin 526 received through a first hole 528A formed at aproximal end of the first link 532A, a second hole 530A formed at aproximal end of the second link 532B, and a third hole 540 formed at adistal end 524 of the actuator rod 516. FIGS. 21-24 illustrate the clampjaw 504 transitioning from an open position in FIG. 21 to a closedposition in FIG. 24 and intermediate positions in FIGS. 22 and 23.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device may be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular elements, and subsequent reassembly. In particular, thedevice may be disassembled, and any number of particular elements orcomponents of the device may be selectively replaced or removed in anycombination. Upon cleaning and/or replacement of particular components,the device may be reassembled for subsequent use either at areconditioning facility, or by a surgical team immediately prior to asurgical procedure. Those skilled in the art will appreciate thatreconditioning of a device may utilize a variety of techniques fordisassembly, cleaning/replacement, and reassembly. Use of suchtechniques, and the resulting reconditioned device, are all within thescope of the present application.

Preferably, the various embodiments described herein will be processedbefore surgery. First, a new or used instrument is obtained and ifnecessary cleaned. The instrument can then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentare then placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation kills bacteria on the instrument and in the container. Thesterilized instrument can then be stored in the sterile container. Thesealed container keeps the instrument sterile until it is opened in themedical facility.

It is preferred that the device is sterilized. This can be done by anynumber of ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, steam, autoclaving, soaking in sterilizationliquid, or other known processes.

Although various embodiments have been described herein, manymodifications and variations to those embodiments may be implemented.For example, different types of end effectors may be employed. Also,where materials are disclosed for certain components, other materialsmay be used. The foregoing description and following claims are intendedto cover all such modification and variations.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. A surgical instrument, comprising: a sheath; anelongated vibrational transmission waveguide positioned at leastpartially within the sheath, the waveguide defining a longitudinal axisand configured to transmit vibrations along the longitudinal axis at apredetermined wavelength, the waveguide comprising: a distal end; aproximal end; at least one node defined between the proximal end and thedistal end; and at least one anti-node defined between the proximal endand the distal end, wherein the locations of the at least one node andthe at least one anti-node between the proximal end and the distal endare determined by the predetermined wavelength of the vibrations; an endeffector acoustically coupled to and extending from the distal end ofthe waveguide, wherein the end effector comprises: an end; and adistal-most anti-node positioned at the end of the end effector; atleast one strike surface formed on the proximal end, the at least onestrike surface being configured to receive vibratory energy in the formof mechanical impacts; at least one compliant member extending betweenthe sheath and the waveguide, wherein the at least one compliant memberis located at the at least one node defined along the waveguide toisolate the vibrations from the sheath; and a cam and lobe arrangementpositioned at the proximal end, wherein the cam is coupled to agenerator to move the cam in a circular path, and wherein the lobe is inmechanical communication with the strike surface on at least one pointon the circular path.
 2. The surgical instrument of claim 1, wherein thegenerator comprises an electric motor.
 3. The surgical instrument ofclaim 1, wherein the generator comprises a hydraulic motor.
 4. Thesurgical instrument of claim 1, wherein the generator comprises apneumatic motor.
 5. The surgical instrument of claim 1, comprising agrip defining a longitudinal channel configured to engage a portion ofthe vibrational transmission waveguide at a distal end of the at leastone strike surface.
 6. A method for processing a surgical instrument forsurgery, comprising: obtaining the surgical instrument of claim 1;sterilizing the surgical instrument; and storing the surgical instrumentin a sterile container.
 7. A surgical instrument, comprising: a sheath;an elongated ultrasonic transmission waveguide positioned at leastpartially within the sheath, the waveguide defining a longitudinal axisand configured to transmit vibrations along the longitudinal axis at anultrasonic wavelength, the waveguide comprising: a distal end; aproximal end; a node defined between the proximal end and the distalend, wherein the location of the node between the proximal end and thedistal end is determined by the ultrasonic wavelength of the vibrations;and an anti-node defined between the proximal end and the distal end,wherein the location of the anti-node between the proximal end and thedistal end is determined by the ultrasonic wavelength of the vibrations;an end effector acoustically coupled to and extending from the distalend of the waveguide, wherein the end effector comprises: an end; and adistal-most anti-node positioned at the end of the end effector; astrike plate coupled to the proximal end of the waveguide; a drive platemoveably positioned adjacent to the strike plate, wherein the driveplate is configured to impart vibratory energy in the form of mechanicalimpacts to the strike plate, and wherein the strike plate couples thevibrations to the waveguide; and a compliant member extending betweenthe sheath and the waveguide, wherein the compliant member is located atthe node of the waveguide to isolate the vibrations from the sheath:wherein the drive plate comprises a cam, wherein the cam is coupled to agenerator that operably moves the cam in a circular path, and whereinthe cam is in mechanical communication with the strike surface on atleast one point on the circular path.
 8. The surgical instrument ofclaim 7, wherein the generator comprises a motor selected from a groupof motors comprising: an electric motor, a hydraulic motor, and apneumatic motor.
 9. The surgical instrument of claim 7, comprising: ahousing to enclose the cam; an annular projection on the waveguide,wherein the housing is mounted to the waveguide at the annularprojection; and a bushing around a portion of the waveguide, wherein thehousing fits over the bushing.
 10. A surgical instrument, comprising: asheath; a waveguide positioned at least partially within the sheath andcomprising: a distal end; a proximal end; at least one node definedbetween the distal end and the proximal end; at least one anti-nodedefined between the distal end and the proximal end; and a longitudinalaxis extending between the proximal end and the distal end, wherein thewaveguide is configured to transmit ultrasonic vibrations along thelongitudinal axis at a predetermined ultrasonic wavelength thatestablishes the locations of the at least one node and the at least oneanti-node between the distal end and the proximal end of the waveguide;an end effector acoustically coupled to and extending from the distalend, wherein the end effector comprises: an end; and a distal-mostanti-node positioned at the end; a strike surface coupled to theproximal end, wherein the strike surface is configured to receivevibratory energy in the form of mechanical impacts, and wherein thestrike surface imparts the vibrations to the waveguide; at least onecompliant member extending between the sheath and the waveguide, whereinthe at least one compliant member is located at the at least one node ofthe waveguide to isolate the vibrations from the sheath; and a drivermoveably positioned adjacent to the strike surface, wherein the driveris configured to impart vibratory energy in the form of mechanicalimpacts to the strike surface, wherein the driver rotates about a hub,and wherein rotation of the driver generates longitudinal vibrationsalong the waveguide.
 11. The surgical instrument of claim 10, whereinthe driver comprises a projection, and wherein the projection impactsthe strike surface as the driver rotates about the hub.
 12. The surgicalinstrument of claim 10, wherein the driver is coupled to a motor thatgenerates rotation thereof.